Analysis of Proteomic Patterns in Serum to Identify Ovarian Cancer
DESCRIPTION
Proteins are the functional units of cells and represent the end product of the interactions among the underlying genes. Proteomics is the study of all protein forms expressed within an organism as a function of time, age, state, and external factors. Cancer research has identified a pattern of proteins present in different body fluids, such as body fluid or serum that are associated with an underlying cancer. Identification of patterns of proteins in the serum could function as serum tumor markers, similar in concept to the prostate specific antigen (PSA) or CA-125, which are used in the detection and monitoring of prostate and ovarian cancer.
CA-125 and transvaginal ultrasound have been proposed as screening techniques for ovarian cancer, particularly in high-risk individuals. However, they have not resulted in a decrease in morbidity, primarily due to the advanced disease stage at diagnosis and the lack of curative therapies at these stages.
The OvaCheck™ (Correlogic Systems) is the first test based on serum proteomic patterns, which are further analyzed with the use of a mass spectrometer to profile groups of proteins based on their size and electrical charge. Patterns are identified that are consistent with ovarian cancer. The manufacturer originally assumed that this test would not be subject to FDA approval. However, the FDA has questioned this assumption. To date, it has not received FDA approval.
Laboratory Corporation of America (LabCorp) introduced OvaSure™, another screening test for the early detection of ovarian cancer. To date, this test has not received FDA approval, however, according to the literature, the test is undergoing further evaluation in a phase III clinical trial in collaboration with the National Cancer Institute’s Early Detection Research Network.
POLICY
Analysis of proteomic patterns in serum for screening and detection of ovarian cancer is considered investigational.
Policies with similar titles: Proteomics-based Testing for the Evaluation of Ovarian (Adnexal) Masses
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ADDITIONAL INFORMATION
July 2, 2008, the Society of Gynecologic Oncologist (SCO) released the following statement regarding OvaSure™:
“The Society of Gynecologic Oncologist (SGO) recognizes the need for accurate early detection biomarkers for ovarian cancer. For this reason, SGO reviewed the literature regarding OvaSure™, a serum-based diagnostic test for ovarian cancer.
After reviewing OvaSure’s materials, it is our opinion that additional research is needed to validate the test’s effectiveness before offering it to women outside of the context of a research study conducted with appropriate informed consent under the auspices of an institutional review board.
SGO is committed to actively following and contributing to this vitally important research. As physicians who care only for women with gynecologic cancers, our hope is that cancers can either be prevented or detected early. Because no currently available test has been shown to reliably detect ovarian cancer in its earliest and most curable stages, we will await the results of further clinical evaluation of OvaSure™ with great interest.”
Published scientific evidence in the form of well-designed studies in peer-reviewed journals regarding the analysis of proteomic patterns in serum to identify ovarian cancer is lacking.
There is insufficient evidence to permit conclusions regarding the use of this technology or benefits compared to established alternative screening methods for ovarian cancer.
SOURCES
Abeloff, M. D., Armitage, J. O., Niederhuber, J. E., Kastan, M. B., & McKenna, W. G. (2008). Clinical Oncology (4th ed., pp. 1828-1848). Philadelphia: Churchill Livingstone Elsevier.
Agency for Healthcare Research and Quality. (2006, October). Genomic tests for ovarian cancer detection and management. Retrieved March 27, 2007 from http://www.ahrq.gov/downloads/pub/evidence/pdf/genomicovc/genovc.pdf.
American Cancer Society. (2010). What’s new in ovarian cancer research and treatment? Retrieved January 18, 2011 from http://www.cancer.org/Cancer/OvarianCancer/DetailedGuide/ovarian-cancer-new-research.
BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2009). Analysis of proteomic patterns in serum to identify ovarian cancer (2.04.34). Retrieved January 14, 2011 from BlueWeb. (17 articles and/or guidelines reviewed)
Chobanian, N. & Dietrich, C.S. (2008). Ovarian cancer. Surgical Clinics of North America, 88 (2), 285-29.
Dann, R.B., Kelley, J.L., & Zorn, K.K. (2007). Strategies for ovarian cancer prevention. Obstetrics and Gynecology Clinics of North America, 34 (4), 667-686.
National Cancer Institute. (2009, August). Proteomics and cancer: Fact sheet. Retrieved January 18, 2011 from http://www.cancer.gov/cancertopics/factsheet/detection/proteomics.
Nossov, V., Amneus, M., Su, F., Lang, J, Tran Janco, J.M.,Reddy, S.T., et al. (2008). The early detection of ovarian cancer: From traditional methods to proteomics. Can we really do better than serum CA-125? American Journal of Obstetrics & Gynecology, 199 (3), 215-223.
Society of Gynecologic Oncologists. (2008, July). Society of Gynecologic Oncologists statement regarding OvaSure™. Retrieved January 18, 2011 from www.sgo.org/WorkArea/downloadasset.aspx?id=1754.
Tinelli, A., Vergara, D., Martignago, R., Leo, G., Pisano, M. & Malvasi, A. (2009). An outlook on ovarian cancer and borderline ovarian tumors: Focus on genomic and proteomics findings. Current Genomics, 10 (4), 240-249.
Vinintin, I., Feng, Z., Longton, G., Ward, D.C., Alvero, A.B., Lai, Y., et al. (2008). Diagnostic markers for early detection of ovarian cancer. Clinical Cancer Research, 14 (4), 1065-1072.
U. S. Department of Health & Human Services. National Institutes of Health. Questions and answers: OvaCheck™ and NCI/FDA ovarian cancer clinical trials using proteomics technology. Retrieved January 18, 2011 from http://home.ccr.cancer.gov/ncifdaproteomics/pdf/OvaCheckQandA.pdf.
ORIGINAL EFFECTIVE DATE: 8/13/2005
MOST RECENT REVIEW DATE: 2/10/2011
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